Blood Products Advisory Committee; Notice of Meeting, 35494-35495 [2010-15018]
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Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Notices
srobinson on DSKHWCL6B1PROD with NOTICES
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Jeffrey Siegel, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 3154,
Silver Spring, MD 20993–0002, 301–
796–2280; or
Stephen Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852, 301–827–6210; or
Sahar M. Dawisha, Office of In Vitro
Diagnostic Devices, Center for Devices
and Radiological Health (HFZ–440),
Food and Drug Administration, 2098
Gaither Rd., rm. 374, Rockville, MD
20850, 240–276–0717.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Systemic Lupus Erythematosus—
Developing Medical Products for
Treatment.’’ This guidance is intended
to assist sponsors in the clinical
development of medical products for
the treatment of SLE. The guidance
addresses the overall development
program and clinical trial designs as
well as specific information on claims,
study design, study duration, efficacy
endpoints, and response criteria.
In the Federal Register of March 29,
2005 (70 FR 15868), FDA announced the
availability of a draft guidance entitled
‘‘Systemic Lupus Erythematosus—
Developing Drugs for Treatment.’’ FDA
received a number of comments on the
draft guidance, which were considered
and incorporated, as appropriate, when
finalizing the guidance. The
recommendations regarding medical
product development for lupus
nephritis were removed from this
guidance and placed into a separate
guidance, the availability of which is
announced elsewhere in this issue of
the Federal Register. Additional organspecific guidances will be developed in
the future. Other changes that were
made include the addition of more
specific examples of trial design and
study endpoints, updating the science,
and minor editorial changes to clarify
specific issues. In addition, input was
obtained from the Center for Biologics
Evaluation and Research and the Center
for Devices and Radiological Health.
This guidance is being issued
consistent with FDA’s good guidance
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practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on developing medical
products for the treatment of SLE. It
does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 312 have been approved
under OMB Control No. 0910–0014; the
collections of information in 21 CFR
part 314 have been approved under
OMB Control No. 0910–0001; the
collections of information in 21 CFR
part 601 have been approved under
OMB Control No. 0910–0338; and the
collections of information in 21 CFR
part 812 have been approved under
OMB Control No. 0910–0078.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm,
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm, or
https://www.regulations.gov.
Dated: June 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–15080 Filed 6–21–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–N–2010–0001]
Blood Products Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Blood Products
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on July 26, 2010, from 8 a.m. to
approximately 5:30 p.m. and July 27,
2010, from 8 a.m. to approximately 1
p.m.
Location: Hilton Washington DC/
North, 620 Perry Pkwy., Gaithersburg,
MD.
Contact Person: Bryan Emery or
Pearline Muckelvene, Center for
Biologics and Research (HFM–71), Food
and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852,
301–827–0314, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014519516. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: On July 26, 2010, in the
morning session, the committee will
hear updates on the following topics:
June 10 and 11, 2010, meeting of the
Department of Health and Human
Services Advisory Committee on Blood
Safety and Availability; December 14
and 15, 2009, FDA workshop on
emerging arboviruses; May 11 and 12,
2010, FDA workshop on emerging
infectious diseases; and the Q fever
epidemic in the Netherlands. The
committee will also hear informational
presentations on Xenotropic Murine
Leukemia Virus-Related Virus. In the
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srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Notices
afternoon session, the committee will
discuss issues related to the risk of
Babesia infection by blood transfusions
and the status of laboratory tests. On
July 27, 2010, the committee will
discuss blood donor hemoglobin/
hematocrit qualifications standards, iron
status, and interdonation interval.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before July 19, 2010. Oral
presentations from the public will be
scheduled between approximately 11:45
a.m. and 12:30 p.m. and between 4 p.m.
and 4:45 p.m. on July 26, 2010, and
between approximately 10:30 a.m. and
11 a.m. on July 27, 2010. Those desiring
to make formal oral presentations
should notify the contact person and
submit a brief statement of the general
nature of the evidence or arguments
they wish to present, the names and
addresses of proposed participants, and
an indication of the approximate time
requested to make their presentation on
or before July 9, 2010. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by July 12, 2010.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Bryan Emery
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
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meetings. Please visit our Web site at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: June 15, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–15018 Filed 6–21–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Ophthalmic Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Ophthalmic
Devices Panel of the Medical Devices
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on July 30, 2010, from 8 a.m. to 6
p.m.
Location: Holiday Inn, Ballroom, 2
Montgomery Village Ave., Gaithersburg,
MD.
Contact Person: James Engles, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm.
1566, Silver Spring, MD 20993–0002, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014512396. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
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35495
about possible modifications before
coming to the meeting.
Agenda: On July 30, 2010, the
committee will discuss, make
recommendations, and vote on a
premarket approval application for the
Glaukos iStent Trabecular Micro-Bypass
Stent, Model GTS–100 L/R, sponsored
by Glaukos Corp. The device is
indicated for use in conjunction with
cataract surgery for the reduction of
intraocular pressure (IOP) in subjects
with mild to moderate open-angle
glaucoma currently treated with ocular
hypotensive medication. For this
device, the patients should have normal
gonioscopic anatomy and a visually
significant cataract eligible for
phacoemulsification. The patient’s
glaucoma should be considered mild to
moderate Primary Open Angle
Glaucoma, or the secondary open angle
glaucomas, Pigmentary Glaucoma and
Pseudoexfoliation Glaucoma. Patients
with other causes of secondary open
angle glaucoma or angle closure
glaucomas are not eligible for use of this
device. Patients’ IOP should be
controlled on 1–3 glaucoma medications
and patients should not previously have
had surgery for glaucoma.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before July 22, 2010. Oral
presentations from the public will be
scheduled approximately between 1
p.m. and 2 p.m. or immediately
following lunch. Those desiring to make
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before July 14, 2010. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
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]]>Agencies
[Federal Register Volume 75, Number 119 (Tuesday, June 22, 2010)]
[Notices]
[Pages 35494-35495]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15018]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-N-2010-0001]
Blood Products Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Blood Products Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on July 26, 2010, from 8
a.m. to approximately 5:30 p.m. and July 27, 2010, from 8 a.m. to
approximately 1 p.m.
Location: Hilton Washington DC/North, 620 Perry Pkwy.,
Gaithersburg, MD.
Contact Person: Bryan Emery or Pearline Muckelvene, Center for
Biologics and Research (HFM-71), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 3014519516. Please call the Information Line
for up-to-date information on this meeting. A notice in the Federal
Register about last minute modifications that impact a previously
announced advisory committee meeting cannot always be published quickly
enough to provide timely notice. Therefore, you should always check the
agency's Web site and call the appropriate advisory committee hot line/
phone line to learn about possible modifications before coming to the
meeting.
Agenda: On July 26, 2010, in the morning session, the committee
will hear updates on the following topics: June 10 and 11, 2010,
meeting of the Department of Health and Human Services Advisory
Committee on Blood Safety and Availability; December 14 and 15, 2009,
FDA workshop on emerging arboviruses; May 11 and 12, 2010, FDA workshop
on emerging infectious diseases; and the Q fever epidemic in the
Netherlands. The committee will also hear informational presentations
on Xenotropic Murine Leukemia Virus-Related Virus. In the
[[Page 35495]]
afternoon session, the committee will discuss issues related to the
risk of Babesia infection by blood transfusions and the status of
laboratory tests. On July 27, 2010, the committee will discuss blood
donor hemoglobin/hematocrit qualifications standards, iron status, and
interdonation interval.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before July
19, 2010. Oral presentations from the public will be scheduled between
approximately 11:45 a.m. and 12:30 p.m. and between 4 p.m. and 4:45
p.m. on July 26, 2010, and between approximately 10:30 a.m. and 11 a.m.
on July 27, 2010. Those desiring to make formal oral presentations
should notify the contact person and submit a brief statement of the
general nature of the evidence or arguments they wish to present, the
names and addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before July
9, 2010. Time allotted for each presentation may be limited. If the
number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by July 12, 2010.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Bryan Emery at least
7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: June 15, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-15018 Filed 6-21-10; 8:45 am]
BILLING CODE 4160-01-S
